Large surface area temperature sensing device

ABSTRACT

A temperature probe for monitoring temperatures of a surface of a tissue or organ within the body of a subject includes a section with a substantially two-dimensional arrangement and a plurality of temperature sensors positioned across an area defined by the substantially two-dimensional arrangement. Such an apparatus may be used in conjunction with procedures in which thermal techniques are used to diagnose a disease state or treat diseased tissue. Specifically, a temperature probe may be used to monitor temperatures across an area of a surface of a tissue or organ located close to the treated tissue to prevent subjection of the monitored tissue or organ to potentially damaging temperatures.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority under 35 U.S.C. §119(e)to U.S. Provisional Patent Application Ser. No. 61/037,624, filed onMar. 18, 2008, the entire disclosure of which is, by this reference,hereby incorporated herein.

TECHNICAL FIELD

The present invention relates generally to apparatuses for monitoringtemperatures of an internal surface of a hollow organ in the body of asubject and, more specifically, to temperature monitoring apparatusesthat are configured to monitor temperatures at different locationsspread over an area of an internal surface of a hollow organ. Thepresent invention also relates to methods in which temperatures acrossareas of an internal surface of a hollow organ are monitored, includingtechniques in which an adjacent tissue or organ is heated or cooled.

BACKGROUND OF RELATED ART

A variety of techniques have been developed in which tissues or organsin a patient's body are heated or cooled. Tissues may be heated by avariety of techniques, including high frequency ultrasound,radiofrequency treatments, laser treatments, use of infrared radiation,and by direct application of thermal energy. Cooling is often effectedcryogenically. Techniques that heat and cool tissues may be collectivelyreferred to as “thermal techniques.”

Thermal techniques are useful for diagnosing a variety of disease statesand for treating a variety of disease states. More specifically, thermaltechniques may be used to diagnose and/or treat cancerous tissues, todestroy diseased tissues, to congeal blood, and to perform a variety ofother diagnostic and surgical procedures. Examples of organs that may besubjected to thermal techniques include the heart, the lungs,gastrointestinal organs, the liver, the pancreas, urological organs,prostates, reproductive organs, and skin.

The degree of heating or cooling that is required to optimize theefficiency of some thermal techniques may adversely affect tissues ororgans that are adjacent to a treated tissue or organ. For example, agreat deal of heat is generated when left atrium ablation techniques areused to treat atrial fibrillation in human subjects. In addition toheating and treating the diseased tissue in the heart H, the esophagusE, which is adjacent to the left atrium LA of the heart H, as shown inFIG. 1, may also be heated. As FIG. 1 illustrates, a typical humanesophagus E typically has a narrow oval shape that resembles a pancake,with a large portion of the outer surface of the esophagus E locatednext to or in contact with the left atrium LA, although the size, shape,and/or position of the esophagus may vary. In an average human adult,about 58 mm of the length and the majority of the front side of a 14 mmdiameter esophagus E is located in proximity to or contacts the leftatrium LA. As a consequence of this intimate arrangement between theesophagus E and the left atrium LA, the heat generated during leftatrium ablation may damage the esophagus and may, in some cases, createan esophageal fistula. Unfortunately, the complications that arise fromesophageal fistula often do not present themselves until weeks after theprocedure and, in many cases, at too late a time to treat and/or curethe sometimes fatal damage that has been done.

In recognition of the potentially dire consequences of overheating theesophagus during left atrial ablation, some physicians have startedusing catheters with single temperature sensors to monitor thetemperature within the subject's esophagus. Typically, a catheter with asize of 9 French (about 3 mm diameter) to about 18 French (about 64 mmdiameter) is used in conjunction with a conventional temperature sensor(e.g., an esophageal stethoscope available from Smiths Medical of Hythe,Kent, United Kingdom). If the sensed temperature reaches a predeterminedlevel, the physician may discontinue the left atrium ablationmomentarily to allow the esophagus to cool. The effectiveness of thesetechniques is limited, however, as a single temperature sensor may onlymonitor heat at a single location within the relatively large area ofthe esophageal wall located adjacent to the left atrium.

In an apparent effort to reduce the likelihood of esophageal fistuladuring left atrium ablation procedures, a variety of different types ofinflatable devices have been developed. Some inflatable devices areconfigured to cool the esophagus during left atrium ablation. Otherinflatable devices are configured to ensure contact between one or moretemperature sensors and the interior surface of the front of theesophageal wall. Despite assertions to the contrary, since the esophagusE is confined between the left atrium LA of the relatively rigid heart Hand the even more rigid vertebral column VC (see FIG. 1), any change inthe shape of the esophagus E by inflating a device that has beenintroduced into the esophagus E merely pushes or distends the esophagusE closer to, or into more intimate contact with, the left atrium LA. Theobvious result of such movement or distension is an increase in thelikelihood that a left atrium ablation procedure will cause anesophageal fistula. In addition, use of an inflatable device willundesirably prevent a subject from swallowing during the typicallylengthy (two to four hour) procedure, which may unnecessarily requirethat the subject be placed under general anesthesia during theprocedure.

SUMMARY

The present invention includes various embodiments of temperature probesconfigured to be positioned against internal organ surfaces. Atemperature probe that incorporates teachings of the present inventionincludes an elongate member and a plurality of temperature sensorscarried at discrete locations along the length of the elongate member.When disposed within the interior of a hollow organ, a section of theelongate member is configured to have a substantially two-dimensionalarrangement that arranges the temperature sensors in an area array. Thearrangement of the shaped section of the elongate member is referred toas a “substantially two-dimensional arrangement” to account for thethicknesses of the elongate element and the temperature sensors carriedthereby, as well as for any slight deviations of the elongate memberfrom a desired plane for the two-dimensional arrangement.

A substantially two-dimensional arrangement of a portion of atemperature probe of the present invention may, in some embodiments, bedefined during manufacture of the temperature probe or apparatus (e.g.,catheters, guide wires, shaping wires, etc.) that are to be usedtherewith. In other embodiments, a temperature probe or an apparatusthat is configured for use therewith may be configured to enable aphysician to define the substantially two-dimensional arrangement.

In some embodiments, the elongate member comprises a flexible elementwith a section that, in a relaxed state, is pre-shaped to a desired,substantially two-dimensional arrangement. Elongate members with suchcharacteristics may take on substantially linear, or one-dimensional,configurations when introduced into a linear catheter under stress but,upon removal of the pre-shaped section from the catheter, the pre-shapedsection returns to its relaxed state, in which it has a substantiallytwo-dimensional arrangement.

In other embodiments, the elongate member is an element that has asubstantially linear, or one dimensional, configuration, but includes asection that may be formed into a substantially two-dimensionalarrangement of desired configuration. A section of an elongate memberthat is ordinarily substantially linear may take on a substantiallytwo-dimensional arrangement when a wire that includes a section with thesubstantially two-dimensional arrangement is introduced into a lumen ofthe elongate member. Such a wire may itself be somewhat flexible orselectively flexible (e.g., depending upon its temperature, etc.), andits introduction into the interior of a hollow organ of a subject's bodymay be enabled by rigidity of a proximal and/or intermediate portion ofelongate element, a property (e.g., shape memory, etc.) of the materialfrom which wire is formed, or by any other suitable means. When theshaped portion of the wire is introduced into a corresponding flexiblesection of the elongate member, that section of the elongate member mayassume the substantially two-dimensional arrangement.

Other embodiments of temperature probes of the present invention includemechanisms for transforming substantially linear sections of elongatemembers to two-dimensional arrangements. In one such embodiment, anelongate element comprises a control wire, along with a multi-elementportion along a portion of the length of the control wire. Themulti-element portion includes at least two parallel arms that carrytemperature sensors. While the multi-element portion is contained withina catheter, it may have a substantially linear configuration. Once thecatheter has been introduced into the interior of a hollow organ, thecontrol wire may be moved distally to push the multi-element portion outof a distal end of the catheter. The control wire may then be drawn backtoward the distal end of the catheter, which engages an actuatorassociated with the at least two parallel arms and causes them to bowoutwardly, forcing the multi-element portion into a substantiallytwo-dimensional arrangement, such as a loop.

Other techniques for causing a section of a temperature probe to assumea substantially two-dimensional configuration (e.g., aspiration of airfrom a lumen extending through a section of the temperature probe,introduction of pressure into a lumen extending through a section of thetemperature probe, manipulation of a section of a temperature probefollowing its introduction into the body of a subject, etc.) are alsowithin the scope of the present invention.

The present invention includes techniques for introducing a temperatureprobe into the body of a subject with the temperature probe in asubstantially linear, or one-dimensional, configuration, then allowingor causing a section of an elongate member of the temperature probe toassume the substantially two-dimensional arrangement when that sectionof the temperature probe is at a desired location within the subject'sbody.

In addition to including various embodiments of temperature probes, thepresent invention also includes embodiments of methods, or procedures,in which the temperatures at various locations over an area of a bodytissue are monitored. When such a procedure is conducted, a first tissueor organ of a subject's body is subjected to a thermal technique whiletemperature is monitored over an area of an adjacent, second tissue ororgan of the subject's body. In some embodiments, the temperature of thesecond tissue or organ may be monitored without substantial deformationof the second tissue or organ, without substantial displacement of thesecond tissue or organ, and/or without preventing the second tissue ororgan from functioning. Additionally, if any portion of the monitoredarea approaches a potentially damaging (cold or hot) temperature,precautionary measures may be taken. Various embodiments suchprecautionary measures include, but are not limited to, temporarytermination of the thermal technique, movement of the affected portionof the second tissue or organ away from the first tissue or organ,and/or changing the temperature of the affected portion of the secondtissue or organ.

In a specific embodiment, the method of the present invention may beeffected during left atrial ablation, which is a surgical procedure thatmay be used to treat atrial fibrillation. During a left atrial ablationprocedure, temperature may be monitored at a plurality of locationsspaced over an area of an interior surface of a front portion of asubject's esophageal wall that is located adjacent to the left atrium ofthe subject's heart. Such temperature monitoring may be effected withoutany substantial change in the shape of the esophagus, without anysubstantially displacement of the monitored portion of the esophagus,and without blocking the esophagus or otherwise preventing the subjectfrom swallowing. If any portion of the sensed area approaches apotentially damaging temperature, cautionary measures may be taken. Invarious embodiments, the left atrial ablation procedure may betemporarily terminated, the heated portion of the esophagus may be movedaway from the left atrium, and/or the heated portion of the esophagusmay be cooled.

Other embodiments of procedures in which thermal techniques are employedare also within the scope of the present invention, including, withoutlimitation, monitoring the temperature of the trachea during ablation ofthe pulmonary vein; monitoring the temperature of the ureters and/orcolon during thermal treatment of the prostate; monitoring thetemperature of and, optionally, flattening a portion of the duodenum ofthe small intestine during thermal treatment of the liver (e.g., totreat hepatic carcinoma, etc.); monitoring the temperature of the cysticduct, gall bladder, and/or stomach during thermal treatment of theliver; monitoring brain temperature through tissues lining the nasalcavities; monitoring the temperature of tissues in the nasal cavitiesduring thermal pharyngeal procedures; and monitoring tissues of oradjacent to the kidneys while breaking up kidney stones.

Other aspects, as well as various features and advantages, of thepresent invention will become apparent to those of ordinary skill in theart through consideration of the ensuing description, the accompanyingdrawings, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a cross-sectional representation of a portion of a human bodyillustrating the relationship between the esophagus and the heart;

FIG. 2 depicts an embodiment of a temperature probe with an elongatemember that includes a section with a substantially two-dimensionalarrangement and temperature sensors arranged along the section of theelongate member in such a way that, when the section is in itssubstantially two-dimensional arrangement, the temperature sensors arearranged in an area array;

FIGS. 2A and 2B illustrate different embodiments of the elongate membersof a temperature probe of the present invention;

FIG. 3 illustrates the embodiment of temperature probe shown in FIG. 2,in a substantially linear, or one-dimensional, configuration whendisposed within a lumen of a catheter having a substantially linear, orone-dimensional, configuration;

FIG. 4 depicts relaxation of a segment of the embodiment of temperatureprobe shown in FIG. 2 to its substantially two-dimensional arrangementupon exiting a distal end of the catheter of FIG. 3;

FIG. 5 shows an embodiment of a temperature probe with an elongatemember that includes a flexible section that, in its relaxed state, maybe substantially linear, or one-dimensional, and that includes aflexible section that carries a plurality of temperature sensors;

FIG. 6 illustrates an embodiment of a shaped wire with a section that,in its relaxed state, has a substantially two-dimensional arrangement;

FIG. 7 depicts introduction of the embodiment of temperature probe shownin FIG. 5 into an interior of a hollow organ of a subject;

FIG. 8 depicts introduction of the shaped wire of FIG. 6 into thetemperature probe of FIG. 5, with the section that has the substantiallytwo-dimensional arrangement deformed to a substantially linear, orone-dimensional, configuration;

FIG. 9 shows the flexible section of the temperature probe of FIG. 5 inthe substantially two-dimensional arrangement when the shaped portion ofthe wire of FIG. 6 assumes its substantially two-dimensional arrangementwithin the flexible section;

FIGS. 10 through 17 depict various embodiments of two-dimensionalconfigurations in which a section of a temperature probe of the presentinvention may be arranged;

FIGS. 18 through 20 illustrate an embodiment of temperature probeconfigured to be mechanically arranged in a substantiallytwo-dimensional arrangement upon being positioned at or near a desiredlocation;

FIGS. 22 and 23 depict embodiments of temperature probes that includesimilar elements to the embodiment shown by FIGS. 18 through 20; and

FIG. 23 schematically depicts use of an embodiment of a temperatureprobe of the present invention in conjunction with a procedure in whicha thermal technique is employed.

DETAILED DESCRIPTION

As shown in FIG. 2, a temperature probe 10 according to an embodiment ofthe present invention includes an elongate member 20 with a proximalportion 22, an intermediate portion 24, and a distal portion 26. Inaddition, temperature probe 10 includes a plurality of temperaturesensors 30 located along one or both of intermediate portion 24 anddistal portion 26. More specifically, temperature sensors 30 arepositioned along a section 28 of elongate member 20 that is configuredto have a substantially two-dimensional arrangement 40 when placedadjacent to or against an area of a surface of a tissue or organ in thebody of a subject. Section 28 may also carry other elements, such asradioopaque markers, echogenic markers, other sensors, and the like. Theshape of the substantially two-dimensional arrangement 40 distributesthree or more temperature sensors 30 over an area (e.g., an area arrayin the depicted embodiment) that is relatively large when compared withthe miniscule area covered by elongate member 20 itself. Temperaturesensors 30 may be arranged across an area array in which at least twosensors 30 spaced laterally (x-axis) apart from each other a firstdistance that exceeds a width of elongate member 20 and at least twosensors 30 spaced vertically (y-axis) apart from each other a seconddistance that is at least as great as the first distance.

Elongate element 20 may, in various embodiments, have a length of about20 cm to about 200 cm. The substantially two-dimensional arrangement 40may have a width that exceeds a diameter of elongate element 20 by atleast ten percent. In a specific embodiment, the substantiallytwo-dimensional arrangement 40 covers an area with a width of about 10mm to about 30 mm and a length of about 40 mm to about 80 mm, althoughsubstantially two-dimensional arrangements that cover narrower areas,wider areas, shorter areas, and longer areas are also within the scopeof the present invention.

In some embodiments, such as that depicted by FIG. 2, section 28 ofelongate member 20 may be configured in the substantiallytwo-dimensional arrangement 40 while in a relaxed state. The materialfrom which elongate member 20 is formed may, in such embodiments, besomewhat flexible and elastic, at least under certain conditions (e.g.,when placed under a load, with or without other conditions), to enableelongation of section 28 from the substantially two-dimensionalarrangement 40 to a more linear, substantially one-dimensional,configuration. For example, section 28 may be elongated when placedunder a load within the lumen 52 of a catheter 50, as shown in FIG. 3.

A variety of materials are suitable for forming a pre-shaped butflexible elongate member 20 (or at least section 28 thereof), includingplastics and metal alloys. In embodiments where section 28 of elongatemember 20 is formed from a plastic, the plastic may comprise apolyester, a polyurethane, a latex, polyvinyl chloride, and thepolyether block amide marketed as PEBAX®. Metals and/or metal alloysthat may be used to form elongate member 20 include, but are not limitedto, shape memory alloys such as the nickel-titanium alloy referred to asNITINOL (for nickel titanium naval ordinance laboratory), steel,nickel-titanium, cobalt-chromium, and the cobalt-based alloy availableunder the trade name ELIGLOY®. An elongate member 20 that is formed froma metal or metal alloy may, in some embodiments, be coated with a softerpolymer to prevent damage to the tissues and organs of the body of asubject into which temperature probe 10 is introduced. In someembodiments, the entire elongate member 20 may be formed from the samematerial, while other embodiments of elongate member 20 have hybridconstructions, such as a metal proximal portion 22 joined to a plasticor shape memory alloy distal portion 26.

As depicted by FIG. 2A, in some embodiments, including embodiments inwhich elongate member 20 is formed from a plastic, elongate member 20may comprise a tubular member with one or more lumens 21 a, 21 b, 21 c(three are shown) extending therethrough. Lumen 21 a of such an elongatemember 20 may be configured to accommodate wires (e.g., thermallyconductive elements or electrically conductive wires 32 that lead totemperature sensors 30, to other sensors, etc.) or other elements oftemperature probe 10. Lumen 21 b may be configured to transport fluidsinto (e.g., fluids that provide a heat sink, cooled fluids to decrease atemperature of the sensed tissue, heated fluids to increase atemperature of the sensed tissue, etc.) or out of the subject's body, orto provide a pathway by which other medical devices may be introducedinto the subject's body. Lumen 21 c of elongate member 20 may beconfigured to receive a guide wire.

As an alternative to wires 32 that extend through an interior (e.g.,through a lumen 21 a) of elongate member 20, wires 32 may be carriedupon an exterior of elongate member 20 (including embodiments in whichelongate member 20 includes one or more lumens 21 a, 21 b, 21 c, as wellas embodiments in which elongate member 20 lacks lumens, or has a solidcross-section), as illustrated by FIG. 2B. Various embodiments ofexternally carried wires 32 include wires that are defined by etching ametal film formed on an external surface of elongate member 20, wiresthat are stamped or printed onto the external surface of elongate member20, and wires that are discrete from, but carried by (e.g., wrappedaround, etc.) the external surface of elongate member 20. Of course, inembodiments where elongate member 20 is formed from a metal or metalalloy, electrically insulative elements (e.g., a dielectric coating,etc.) (not shown) may electrically isolate wires 32 that are carried bythe exterior surface of elongate member 20 from the material of elongatemember 20.

As depicted by FIG. 2B, in some embodiments, elongate member 20 may havea solid cross section.

Each temperature sensor 30 of temperature probe 10 may comprise anysuitable type of temperature sensor known in the art. In variousembodiments, thermocouples or thermistors that have been swaged to metalor thermally conductive (e.g., platinum, platinum-iridium, gold, etc.)sensors may be used as temperature sensors 30. Each temperature sensor30 may comprise a single element configured to detect a singletemperature at a particular location. Alternatively, one or moretemperature sensors 30 of a temperature probe 10 of the presentinvention may include a plurality of ganged temperature sensingelements, each of which may sense and/or report a different temperatureto provide a more accurate temperature reading at a particular location.

Wires 32 that communicate with temperature sensors 30 (or withindividual temperature sensing elements of a sensor 30) extendproximally along elongate member 20 to a suitable connector 34associated with proximal portion 22 of elongate member 20. In someembodiments, connector 34 may comprise a known 400 series connector or aknown series 700 connector, such as, or similar to, those manufacturedby Datex Ohmeda, GE Medical, Nihon Kohden, or Vital Signs, Inc.

Connector 34 enables connection of wires 32 and, thus, thermal sensors30 to a suitable temperature monitor (not shown) that, in turn,communicates with a processing element (not shown) associated with atemperature display system 36. In the depicted embodiment, displaysystem 36 includes a display element 37 that shows the temperatures 38a, 38 b, etc., monitored at various locations that correspond to thelocations of temperature sensors 30 in the substantially two-dimensionalarrangement 40 of section 28 of elongate member 20. Temperatures 38 a,38 b, etc., may be visually arranged in a manner that corresponds to thephysical arrangement of temperature sensors 30 across the substantiallytwo dimensional configuration 40. Additionally, display system 36 mayclearly identify the warmest and coolest sensed temperatures 38 a, 38 b,etc. (e.g., by color, such as red and blue, respectively; by fast andslow flashing, respectively; etc.). Display system 36 may also present arate 39 at which a sensed temperature is changing. The rate oftemperature change may be displayed numerically or, as depicted,graphically.

With reference to FIG. 3, an embodiment of a method for introducing atemperature probe 10 into a body of a subject is depicted. Specifically,temperature probe 10 is introduced into a lumen 52 of a substantiallylinear, or one-dimensional, catheter 50. Catheter 50 is sufficientlyrigid to cause section 28 of elongate element 20 of temperature probe 10to flex and, thus, to straighten while catheter 50 maintains itssubstantial linearity. In some embodiments, catheter 50 may also besufficiently flexible to move through curved cavities or vessels. Withthe non-linear, substantially two-dimensional arrangement 40 (FIG. 2) ofelongate element 20 of temperature probe 10 confined within lumen 52 ofcatheter 50 in a substantially linear configuration, temperature probe10 may be easily introduced into a hollow area H within the body of asubject.

Once distal portion 26 of elongate element 20 of temperature probe 10has been positioned within hollow area H, distal portion 26 and section28 may be pushed out of a distal end 54 of lumen 52 and into hollow areaH, where section 28 may assume its relaxed, substantiallytwo-dimensional arrangement 40, as shown by FIG. 4.

As an alternative to the use of a catheter to straighten temperatureprobe 10 and introduce a distal portion 26 of the same into hollow areaH, a proximal end of a guide wire whose distal end has already beenintroduced into hollow area H may be introduced into a lumen 21 c (FIG.2A) of elongate member 30. The rigidity of the guide wire may besufficient to straighten section 28 of elongate member 30, facilitatingits introduction into hollow area H. Once section 28 has been introducedto a desired location, the guide wire may be removed from lumen 21 c,allowing section 28 to assume the substantially two-dimensionalarrangement 40.

Another embodiment of temperature probe 10′ of the present invention isdepicted by FIGS. 5 through 9. As depicted by FIG. 5, temperature probe10′ comprises a substantially one-dimensional elongate element 20′ withthe same features as elongate element 20 (FIG. 2), with the primaryexception being that section 28′ of elongate element 20′ is not shapedto have a substantially two-dimensional configuration 40 (FIG. 2).Instead, section 28′ of elongate element 20′ of temperature probe 10′ isflexible, and may be deformed to take on a substantially two-dimensionalconfiguration 40 (FIG. 2)

As depicted by FIGS. 6 and 7, a lumen 21′ that extends through thelength of elongate element 20′ is configured to receive a shaped wire60. As shown in FIG. 6, prior to its introduction into lumen 21′, shapedwire 60 includes a section 62 that, in its relaxed state, has asubstantially two-dimensional arrangement 64. Shaped wire 60 is aflexible element that may be substantially straightened. In variousembodiments, shaped wire 60 may be formed from a somewhat rigid, yetflexible plastic or a metal or metal alloy, such as a shape memory alloythat is flexible at room temperature, but that becomes rigid when heated(e.g., to a subject's body temperature, etc.).

FIG. 7 illustrates the introduction of distal and intermediate portions26′ and 24′ of elongate element 20′ of temperature probe 10 into ahollow area H of the body of a subject. As elongate element 20′ isintroduced into hollow area H, so are temperature sensors 30 that arecarried by section 28′. Due to its substantially linear, orone-dimensional configuration, known techniques may be used to introduceelongate element 20′ into hollow area H.

Thereafter, shaped wire 60 may be introduced into lumen 21′ of elongateelement 20′ of temperature probe 10′, as illustrated by FIG. 8. Asshaped wire 60 is introduced into lumen 21′, section 62 of shaped wire60 may be deformed (e.g., by the rigidity of a proximal portion 22′and/or intermediate portion 24′ (FIG. 5) of elongate element 21′, bytemperature-dependent flexibility, etc.) to render section 62substantially linear, or to have a one-dimensional configuration. Suchdeformation of section 62 enables shaped wire 60 to be easily introducedinto a temperature probe 10′ that has been inserted into hollow area H.

When section 62 (FIG. 6) of shaped wire 60 has been introduced intosection 28′ of elongate element 20′ of temperature probe 10′, section 62may assume the substantially two-dimensional arrangement 64 (e.g., dueto flexibility of section 28′, upon being heated to or beyond atransition temperature, etc.), as depicted by FIG. 9. As section 62 ofshaped wire 60 assumes the substantially two-dimensional arrangement 64,the flexibility of section 28′ also allows it to be drawn into acorresponding, substantially two-dimensional arrangement 40′. Withsection 28′ of elongate element 20′ in the substantially two-dimensionalarrangement 40′, temperature sensors 30 (FIG. 5) that are carried bysection 28′ are spread across an area defined by the substantiallytwo-dimensional arrangement 40.

Referring now to FIGS. 10 through 16, various embodiments ofsubstantially two-dimensional arrangements 40 are depicted along withpossible arrangements of temperature sensors 30. Specifically, FIGS. 10through 12 show different embodiments of serpentine, or S, arrangements,while FIGS. 13 and 14 depict examples of spiral, or pigtail,arrangements, and FIGS. 15 and 16 illustrate different loopedarrangements. Of course, substantially two-dimensional arrangements 40of other shapes and configurations are also within the scope of thepresent invention.

FIG. 17 illustrates a forked embodiment of temperature probe 10″ with anenlarged distal portion 22″ that includes two or more substantiallyparallel arms 22 a″, 22 b″, etc. (the depicted embodiment includes adistal portion 22″ with three arms 22 a″, 22 b″, and 22 c′). Asillustrated, each arm 22 a″, 22 b″, and 22 c″ carries at least onetemperature sensor 30. In some embodiments, one or more arms 22 a″, 22b″, 22 c″, etc., may carry more than one temperature sensor 30.

FIGS. 18 through 20 illustrate another embodiment of temperature probe100, which is configured to be mechanically arranged in a substantiallytwo-dimensional arrangement upon being positioned at or near a desiredlocation.

As shown in FIG. 18, temperature probe 100 includes an introductorycatheter 150, an elongate element 120 at least partially carried byintroductory catheter 150, and a plurality of temperature sensors 30carried by a distal portion 126 of elongate element 120.

Elongate element 120 includes a proximally located pull wire 121. A userengagement element 110 is associated with a proximal end 122 of pullwire 121 to facilitate movement of elongate element 120 through a lumen152 of introductory catheter 150. Pull wire 121 may extend alongsubstantially the entire length of elongate element 120. In the depictedembodiment, an intermediate portion 124 of pull wire 121 extends througha slip ring 125, to which proximal ends 128 of two or more loop wires127 are secured. Each loop wire 127 carries at least one temperaturesensor 30 and, as depicted, at least one loop wire 127 may carry aplurality of temperature sensors 30. Distal ends 129 of loop wires 127are secured to pull wire 121 at or near its distal end 126. In someembodiments, distal ends 129 of loop wires 127 may be fixedly secured topull wire 121.

Distal end 126 of pull wire 121 may be configured or covered with anelement that prevents trauma to the tissues of a subject as pull wire121 is advanced distally and distal portion 126 exits introductorycatheter 150.

In the arrangement shown by FIG. 18, loop wires 127 are contained withinlumen 152 to introductory catheter 150. This arrangement facilitates theintroduction of a distal portion of temperature probe 100 into a hollowarea of a subject's body. Once the distal portion of temperature probe100 has been placed at a desired location, elongate element 120 may bepushed distally through lumen 152 until proximal ends 128 of loop wires127 and slip ring 125 have exited a distal end 154 of lumen 152, asdepicted by FIG. 19.

Thereafter, as shown in FIG. 20, pull wire 121 may be proximallywithdrawn. As pull wire 121 is proximally withdrawn, slip ring 125,proximal ends 128 of loop wires 127, and/or an engagement element (notshown) associated with slip ring 125 or with proximal ends 128 engagedistal end 154 of introductory catheter 150. As pull wire 121 is furtherwithdrawn and proximal ends 128 are held into place relative to distalend 154, loop wires 127 bow outwardly, providing a distal portion oftemperature probe 100 with a substantially two-dimensional arrangement140. While the distal portion of temperature probe 100 is in thesubstantially two-dimensional arrangement 140, temperature sensors 30that are carried by loop wires 127 are spread across an area defined bythe substantially two-dimensional arrangement 140. The area over whichloop wires 127 spread depends, of course, upon the degree to which pullwire 121 is withdrawn.

With reference again to FIG. 18, user engagement element 110 and pullwire 121 may associated with each other in such a way as to impart auser with control over an orientation of the substantiallytwo-dimensional arrangement 140. In some embodiments, user engagementelement 110 and pull wire 121 may be manipulated to enable deflection(e.g., of up to about 5°, etc.) of the substantially two-dimensionalarrangement 140 in any direction relative to an axis of elongate element120.

A position of pull wire 121 relative to introductory catheter 150 and,thus, the substantially two-dimensional arrangement of the proximalportion of temperature probe 100, may be maintained by causing a lockingelement 159 associated with a proximal end 158 of introductory catheterto engage a proximal portion 122 of pull wire 121 (e.g., by screwinglocking element 159 down into proximal portion 122, etc.).

Instead of requiring that distal portion 126 of pull wire 121 bepartially withdrawn into lumen 152 of catheter 150 to expand loop wires127, in other embodiments, a flexible element, such as a balloon 170enclosed within a mesh basket 180 or a mesh basket 180 alone, may besecured to loop wires 127, as shown in FIGS. 21 and 22, respectively.Balloon 170 may be inflated by known techniques. Mesh basket 180 maycomprise a compressed element that, when removed from lumen 152 ofintroductory catheter 150, automatically expands. Mesh basket 180 mayhave a substantially two-dimensional configuration (e.g., having anarrow oval, or pancake, cross-sectional shape, etc.) so as to minimizeor even prevent manipulation of the shape, displacement, and/or blockageof the hollow organ within which either of these elements are placed. Inembodiments including a balloon 170, mesh basket 180 may constrain theshape of the balloon to the substantially two-dimensional configuration.In some embodiments, balloon 170 or mesh basket 180 may carrytemperature sensors 30.

With reference now to FIG. 23, an embodiment of a method, or procedure,is depicted in which an embodiment of temperature probe 10 of thepresent invention is used to monitor temperatures at a plurality oflocations across an area of a surface S of second tissue or an organ T₂in the body of a subject as a first tissue or organ T₁ of the subject'sbody is subjected to a thermal technique. A plurality of temperaturesensors 30 distributed across an area defined by a substantiallytwo-dimensional arrangement 40 of a section 28 of an elongate element 20is placed against surface S. Section 28 may be placed against surface Swithout substantially deforming surface S or the shape of second tissueor organ T₂ of which surface S is a part, without substantiallydisplacing any part of second tissue or organ T₂, and/or withoutpreventing second tissue or organ T₂ from functioning properly as thetemperature of surface S is monitored. In some embodiments, section 28may deform slightly to conform to a shape of surface S.

If any portion of the monitored area of surface S approaches apotentially damaging (cold or hot) temperature, precautionary measuresmay be taken. Various embodiments such precautionary measures include,but are not limited to, temporary termination of the thermal technique,changing the temperature of the affected portion of second tissue ororgan T₂, and/or movement of the affected portion of second tissue ororgan T₂ away from first tissue or organ T₁. Various embodiments formoving the affected portion of second tissue or organ T₂ include, butare not limited to, deformation of second tissue or organ T₂ to aflattened (e.g., narrowed oval) shape (e.g., by modifying an areaoccupied by the substantially two-dimensional arrangement 40 of section28, etc.), manipulation of a position of temperature sensor 10 withinthe body of the subject to move a portion of second tissue or organ T₂,or any other suitable technique for moving tissue with temperaturesensor 10.

Although the foregoing description contains many specifics, these shouldnot be construed as limiting the scope of the present invention, butmerely as providing illustrations of some embodiments. Similarly, otherembodiments of the invention may be devised which lie within the scopeof the present invention. Features from different embodiments may beemployed in combination. The scope of the invention is, therefore,indicated and limited only by the appended claims and their legalequivalents, rather than by the foregoing description. All additions,deletions and modifications to the invention as disclosed herein whichfall within the meaning and scope of the claims are to be embracedthereby.

1. A temperature probe configured for introduction against an interiorsurface of an organ, comprising: an elongate member including: a distalportion for insertion into an interior of a hollow organ of a subjectand including a portion configured to have a substantiallytwo-dimensional arrangement when present within the interior of thehollow organ, the substantially two-dimensional arrangement having alength that coincides with a remainder of a length of the elongatemember, a width that exceeds a width of the elongate member, and athickness of about a same thickness of the elongate member and anyadditional elements carried by the distal portion of the elongatemember; and a proximal portion adjacent to an opposite end of theelongate member from the distal portion, the proximal portion configuredfor communication with apparatus external to a body of the subject; anda plurality of temperature sensors carried by the distal portion so asto be arranged across an area array when the distal portion is in thesubstantially two-dimensional arrangement, the area array including atleast two sensors spaced laterally (x-axis) apart from each other afirst distance that exceeds a width of the elongate member and at leasttwo sensors spaced vertically (y-axis) apart from each other a seconddistance that is at least as great as the first distance.
 2. Thetemperature probe of claim 1, wherein a combined width of thesubstantially two-dimensional section of at least the portion of thedistal portion of the elongate member and the plurality of temperaturesensors carried by the distal portion is configured to reside within theinterior of the hollow organ without substantially deforming across-sectional shape of the interior of the hollow organ.
 3. Thetemperature probe of claim 1, wherein the distal portion of the elongatemember includes a single element.
 4. The temperature probe of claim 3,wherein at least the portion of the distal portion of the elongatemember is configured to have a substantially two-dimensional arrangementcomprising a serpentine configuration.
 5. The temperature probe of claim4, wherein the width of the substantially two-dimensional arrangementcorresponds to a lateral (x-axis) distance between two laterallydivergent portions of the serpentine configuration of thetwo-dimensional arrangement.
 6. The temperature probe of claim 4,wherein the width of the substantially two-dimensional arrangementcorresponds to a distance between at least two adjacently positioned,spaced apart portions of the distal portion.
 7. The temperature probe ofclaim 3, wherein at least the portion of the distal portion of theelongate member is configured to have a substantially two-dimensionalarrangement comprising a spiral configuration or a looped configuration.8. The temperature probe of claim 7, wherein the width of thesubstantially two-dimensional arrangement corresponds to a distancebetween at least two adjacently positioned, spaced apart portions of thedistal portion.
 9. The temperature probe of claim 1, wherein the distalportion of the elongate member includes at least two substantiallyparallel elongate elements, each elongate element carrying at least onetemperature sensor, at least one elongate element carrying a pluralityof temperature sensors.
 10. The temperature probe of claim 1, furthercomprising: a catheter for introducing at least the distal portion ofthe elongate member into the interior of the hollow organ.
 11. Thetemperature probe of claim 1, wherein: the catheter includes a lumenthat holds the elongate member in a substantially linear configurationuntil a distal end of the elongate member is positioned at apredetermined location within the interior of the hollow organ; and atleast the portion of the distal portion of the elongate member, uponbeing withdrawn from the catheter, assumes the substantiallytwo-dimensional arrangement.
 12. The temperature probe of claim 11,wherein at least the distal portion of the elongate member comprises apreshaped flexible element constrained to the substantially linearconfiguration when positioned within the lumen of the catheter and toassume the substantially two-dimensional configuration upon removal fromthe lumen of the catheter.
 13. A temperature probe configured forintroduction into an interior of a hollow organ, comprising: an elongatemember including a portion configured to have a substantiallytwo-dimensional arrangement when present within an interior of a holloworgan of a subject, the substantially two-dimensional arrangement havinga width that exceeds a width of the elongate member, and a thickness ofabout a same thickness as the elongate member and any additionalelements carried by the elongate member; and a plurality of temperaturesensors carried by the substantially two-dimensional arrangement of theelongate member so as to be arranged in an area array when the portionof the elongate element is in the substantially two-dimensionalarrangement, the area array including at least two sensors spacedlaterally (x-axis) apart from each other a first distance that exceeds awidth of the elongate member and at least two sensors spaced vertically(y-axis) apart from each other a second distance that is at least asgreat as the first distance.
 14. The temperature probe of claim 13,wherein the elongate member is preformed to have the substantiallytwo-dimensional arrangement in a relaxed state.
 15. The temperatureprobe of claim 13, wherein a distal portion of the elongate memberincludes a plurality of arms defining the substantially two-dimensionalarrangement.
 16. The temperature probe of claim 15, further comprisingan actuation mechanism for causing the plurality of arms to spread overan increased area.
 17. The temperature probe of claim 15, wherein theplurality of arms automatically spread across an increased area uponremoval of the distal portion of the elongate member from a catheter.18. A method for treating a subject, comprising: treating a first organof the subject with heat or cold; and monitoring a temperature across anarea of an interior surface of an adjacent, second organ withoutaltering a shape of the second organ or increasing contact or decreasingspacing between the second organ and the first organ.
 19. The method ofclaim 18, wherein monitoring the temperature includes preventing heatingor cooling of the second organ to a damaging temperature.
 20. The methodof claim 19, wherein: treating the first organ comprises atrialfibrillation; and monitoring the temperature across the area of theinterior surface of the second organ comprises monitoring thetemperature across an area of an interior surface of an esophagus toprevent formation of an esophageal fistula.